Trial Outcomes & Findings for Developing and Validating Fertilit-e (NCT NCT03599661)
NCT ID: NCT03599661
Last Updated: 2025-01-09
Results Overview
To evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
Recruitment status
TERMINATED
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Fertilit-e
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Fertilit-e
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Overall Study
Lost to Follow-up
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9
|
Baseline Characteristics
Developing and Validating Fertilit-e
Baseline characteristics by cohort
| Measure |
Fertilit-e
n=12 Participants
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Age, Continuous
|
30.0 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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12 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsTo evaluate Fertilit-e alpha, we will examine its usability through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
Outcome measures
| Measure |
Fertilit-e
n=12 Participants
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Homepage · Usable
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4 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Homepage · Not usable
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8 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Risks/Options · Usable
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6 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Risks/Options · Not usable
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6 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Personal Stories · Usable
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9 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Personal Stories · Not usable
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3 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Financial Concerns · Usable
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8 Participants
|
|
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Financial Concerns · Not usable
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4 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
FAQ · Usable
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9 Participants
|
|
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
FAQ · Not usable
|
3 Participants
|
|
Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Personal Summary · Usable
|
5 Participants
|
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Evaluation of Fertilit-e Alpha - Usability (Number of Participants)
Personal Summary · Not usable
|
7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo evaluate Fertilit-e alpha, we will examine its usability through the System Usability Scale, a simple, ten-item attitude Likert scale (1 - strongly disagree to 5 strongly agree) giving a global view of subjective assessments of usability. The score range is 0 to 100. Higher scores are better and scores above 68 are considered above average.
Outcome measures
| Measure |
Fertilit-e
n=12 Participants
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Evaluation of Fertilit-e Alpha- Usability (System Usability Scale)
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85.0 score on a scale
Standard Deviation 15.5
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SECONDARY outcome
Timeframe: 6 monthsPopulation: All 12 participants for Personal Stories, FAQ, and Personal Summary did not provide data for these themes.
To evaluate Fertilit-e alpha, we will examine its comprehensibility and design through a series of think aloud interviews. Qualitative analysis will provide an integrative summary and identification of key points, potential themes, and areas of further exploration.
Outcome measures
| Measure |
Fertilit-e
n=12 Participants
Participants review Fertilit-e content, undergo interviews about issues of content, functionality, and ease of use, and complete questionnaires over 45-60 minutes.
Interview: Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
Questionnaire Administration: All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
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|---|---|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Homepage · Comprehensible
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8 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Homepage · Not comprehensible
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4 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Risks/Options · Comprehensible
|
9 Participants
|
|
Evaluation of Fertilit-e Alpha- Comprehensibility
Risks/Options · Not comprehensible
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3 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Personal Stories · Comprehensible
|
5 Participants
|
|
Evaluation of Fertilit-e Alpha- Comprehensibility
Personal Stories · Not comprehensible
|
1 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Financial Concerns · Comprehensible
|
4 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Financial Concerns · Not comprehensible
|
8 Participants
|
|
Evaluation of Fertilit-e Alpha- Comprehensibility
FAQ · Comprehensible
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5 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
FAQ · Not comprehensible
|
1 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Personal Summary · Comprehensible
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0 Participants
|
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Evaluation of Fertilit-e Alpha- Comprehensibility
Personal Summary · Not comprehensible
|
0 Participants
|
Adverse Events
Fertilit-e
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephanie Bunch
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-5180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place